Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery

Completed · Phase 3

Conditions studied: Breast Cancer

In brief

Primary Objective: To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased immediate post-operative pain compared with patients having only general anesthesia. Secondary Objectives: 1. To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased post-operative pain in the first 24 hours after surgery compared with patients having only general anesthesia. 2. To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased post-operative nausea and vomiting in the first 24 hours as compared with patients having only general anesthesia. 3. To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in a decreased length of hospital stay compared with patients having only general anesthesia.

Key facts

Study ID

NCT00542542

Run by

M.D. Anderson Cancer Center

People needed

89

Starts

2007-09-01

Expected to finish

2014-03-01

Last updated by the study team

2015-04-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients that consent to participate
• Patients undergoing reconstructive breast surgery either in combination with oncologic surgery or alone
• Patients that are female
• Patients that are over the age of 18
• Patients on anti-coagulants or other blood thinning medications will be eligible for inclusion if they stop taking these medications for at least the time specified below prior to date of surgery: Low molecular weight heparin must stop at least 36 hours prior to surgery. Coumadin must stop at least 5 days prior to surgery. Aspirin, Plavix and NSAIDs must stop at least 7 days prior to surgery.

You may not qualify if…

• Patients on chronic anti-emetics (ie. chronic= more than once every two days for greater than 2 weeks)
• Patients on chronic pain medication (ie. chronic= more than once every two days for greater than 2 weeks) excluding Aspirin, acetaminophen and NSAID's
• Patients with BMI<20 or >40
• Patients that are pregnant
• Patients with chronic pain syndromes.
• Patients with hypersensitivity to ropivacaine/amide-type anesthetics should be excluded from this trial as this would be a contraindication

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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